The Role of Animal Models in Evaluating Reasonable Safety and Efficacy for Human Trials of Cell-Based Interventions for Neurologic Conditions
| Autor: | Joanne Kurtzberg, David M. Blass, Kirby Smith, Michael V. Johnston, Alan Regenberg, Andrew W. Siegel, Joseph T. Coyle, Hilary Bok, Jeremy Sugarman, John W. McDonald, Jeffrey P. Kahn, Richard T. Johnson, S. Matthew Liao, Angelo L. Vescovi, Patricia A. King, Ahmet Hoke, Douglas A. Kerr, Argye E. Hillis, Julia Finkel, Hongjun Song, John D. Gearhart, Henry T. Greely, Karin B. Nelson, Guy M. McKhann, Davor Solter, Wise Young, Richard J. Traystman, Debra J. H. Mathews, Mahendra S. Rao, Ruth R. Faden, Patrick S. Duggan |
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| Přispěvatelé: | Regenberg, A, Mathews, D, Blass, D, Bok, H, Coyle, J, Duggan, P, Faden, R, Finkel, J, Gearhart, J, Hillis, A, Hoke, A, Johnson, R, Johnston, M, Kahn, J, Kerr, D, King, P, Kurtzberg, J, Liao, S, Mcdonald, J, Mckhann, G, Nelson, K, Rao, M, Siegel, A, Smith, K, Solter, D, Song, H, Sugarman, J, Vescovi, A, Young, W, Greely, H, Traystman, R |
| Rok vydání: | 2008 |
| Předmět: |
Predictive validity
Safety Management medicine.medical_specialty Pathology Models Neurological Psychological intervention MEDLINE Context (language use) Article animal models human trial cell-based interventions Risk Factors Intervention (counseling) medicine Animals Humans Intensive care medicine Clinical Trials as Topic business.industry Clinical trial Neurology Models Animal Spite Neurology (clinical) Cardiology and Cardiovascular Medicine business human activities Cell based |
| Zdroj: | Journal of Cerebral Blood Flow & Metabolism. 29:1-9 |
| ISSN: | 1559-7016 0271-678X |
| Popis: | Progress in regenerative medicine seems likely to produce new treatments for neurologic conditions that use human cells as therapeutic agents; at least one trial for such an intervention is already under way. The development of cell-based interventions for neurologic conditions (CBI-NCs) will likely include preclinical studies using animals as models for humans with conditions of interest. This paper explores predictive validity challenges and the proper role for animal models in developing CBI-NCs. In spite of limitations, animal models are and will remain an essential tool for gathering data in advance of first-in-human clinical trials. The goal of this paper is to provide a realistic lens for viewing the role of animal models in the context of CBI-NCs and to provide recommendations for moving forward through this challenging terrain. © 2009 ISCBFM All rights reserved. |
| Databáze: | OpenAIRE |
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